A Study to Evaluate ICP-022 in Patients With R/R PCNSL and SCNSL

Secondary Central Nervous System Lymphoma Clinical Trial

Official title:

A Phase II, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of ICP-022 in Patients With Recurrent/Refractory Central Nervous System Lymphoma and Recurrent/Refractory Secondary Central Nervous System Lymphoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04438044
• Other study ID #: ICP-CL-00106
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 18, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Beijing InnoCare Pharma Tech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.

Description:

Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with Recurrent/Refractory Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL) will be evaluated in approximately 82 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

1. Men and women = 18, and =75 years of age

2. Histologically documented PCNSL, or histologically documented systemic diffuse large B-cell lymphoma (DLBCL) for SCNSL.

3. Subjects with refractory or relapsed disease, one prior CNS directed therapy, and = 4 systemic treatments.

4. ECOG performance status of 0-2

5. Able to provide signed written informed consent

Key Exclusion Criteria:

1. Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded

2. T-cell lymphoma.

3. Patient requires more than 8 mg of dexamethasone daily or the equivalent.

4. Non-hematological toxicity must recover to = Grade 1 from prior anti-cancer therapy (except for alopecia)

5. Known active infection with HBV, HCV or HIV.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Lymphoma
• Neoplasm Metastasis
• PCNSL
• Secondary Central Nervous System Lymphoma

Intervention

Drug:
• ICP-022
ICP-022 The drug product is a white, round, uncoated tablet

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Tiantan Hospital affiliated to Capital Medical University	Beijing	Beijing
China	Capital Medical University Xuanwu Hospital	Beijing	Beijing
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Huashan Hospital affiliated to Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Beijing InnoCare Pharma Tech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy measured by overall response rate (ORR)		Cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days
Secondary	The occurrence of adverse events and serious adverse events	The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria	every cycle, first cycle every week. Each cycle is 28 days
Secondary	The efficacy measured by progression free survival (PFS)		cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days
Secondary	The efficacy measured by duration of response (DOR)		cycle 1-6 once every 2 cycles; monre than 6 cycles once every 3 cycles. Each cycle is 28 days